The Effect of a Biofilm-disrupting Wound Gel vs. a Broad-spectrum Antimicrobial Ointment on a Chronic Wound Microbiome: A Secondary Analysis Associating Clinical and Laboratory Findings

Abstract

Advancement in wound bioburden diagnostics continues to evolve highlighting the need to link laboratory findings to clinical practice. This study aims to determine if laboratory data from a previously published study supports a correlation between use of a novel biofilm-disrupting wound gel and lower bacterial bioburden, wound size reduction, and improved healing. This is a secondary data analysis of a multicenter, prospective, randomized, open-label clinical trial performed from September 2014 through March 2016. The trial compares treatment outcomes of standard of care either with a wound gel (experimental) or triple-antibiotic maximum-strength ointment (control) looking at differences in bioburden measured at time zero (baseline) and after 4 weeks of treatment. Quantitative real-time PCR testing for bacteria and fungi, including testing for resistance factors to vancomycin and methicillin or using proprietary genetic sequencing, was used for analysis. Low or medium bacterial load at baseline correlated to an average reduction in wound size of 40% and 24%, respectively, whereas there was a 19% increase in size among wounds with a high bioburden. Reducing wound bioburden could result in a clinically relevant change in the healing trajectory. In this study, wound size reduction and increased healing percentages were superior in the experimental group.